Table 4 HADR frequency of biosimilars and their biologicals authorized by the EMA.

From: Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure

BIOSIMILARS

Very common

N (%)

Common

N (%)

Uncommon

N (%)

Rare

N (%)

Very rare

N (%)

Not known

N (%)

Any frequency

N (%)

INN level

ANY HADR

6 (31.58)

10 (52.63)

7 (36.84)

8 (42.11)

2 (10.53)

3 (15.79)

14 (73.68)

ANEMIA

3 (15.79)

7 (36.84)

3 (15.79)

7 (36.84)

1 (5.26)

0 (0.00)

14 (73.68)

LEUCOPENIA

4 (21.05)

4 (21.05)

3 (15.79)

3 (15.79)

0 (0.00)

1 (5.26)

7 (36.84)

THROMBOCYTOPENIA

4 (21.05)

4 (21.05)

4 (21.05)

4 (21.05)

0 (0.00)

1 (5.26)

10 (52.63)

MA level

ANY HADR

41 (42.71)

61 (63.54)

46 (47.92)

36 (37.50)

10 (10.42)

17 (17.71)

78 (81.25)

ANEMIA

25 (26.04)

35 (36.46)

20 (20.83)

35 (36.46)

4 (4.17)

0 (0.00)

79 (82.29)

LEUCOPENIA

33 (34.38)

23 (23.96)

12 (12.50)

20 (20.83)

0 (0.00)

6 (6.25)

45 (46.88)

THROMBOCYTOPENIA

29 (30.21)

27 (28.13)

23 (23.96)

21 (21.88)

0 (0.00)

7 (7.29)

62 (64.58)

  1. HADR, Hematological Adverse Drug Reaction; INN, International Nonproprietary Name; MA, Marketing Authorization.